TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM- hydrocortisone cream

TrueLipids 1% Hydrocortisone Barrier Cream by

Drug Labeling and Warnings

TrueLipids 1% Hydrocortisone Barrier Cream by is a Otc medication manufactured, distributed, or labeled by Claridei Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient.........Purpose

Hydrocortisone 1% .....Anti-itch

PURPOSE

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• psoriasis
• poison ivy, oak, sumac
• insect bites
• detergents
• soaps
• cosmetics
• jewelry
• seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if

• condition worsens
• rectal bleeding occurs
• symptoms persist more than 7 days or clear up and occur again within a few days. do not begin use of any other hydrocortisone product unless you have asked a doctor

WARNINGS

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge. consult a doctor
• for the treatment of diaper rash. consult a doctor

when using this product

avoid contact with eyes

do not use more than directed unless told to do so by a doctor

do not put directly into rectim by using fingers or any mechanical device or applicator

DOSAGE & ADMINISTRATION

Directions

• for itching of skin irritation, inflammation and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
  • children under 2 years of age: ask a doctor
  • for external anal and genital itching adult:
    • when practical clean the affected area with mild soap and water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissueor a soft cloth before applying

INACTIVE INGREDIENT

Inactive ingredients

Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol

OTHER SAFETY INFORMATION

Other information

store at 20°-25ºC (68º-77ºF)

PRINCIPAL DISPLAY PANEL

CLMD

Sensitive Skin Care

True Lipids

1% Hydrocortisone Barrier Cream

Net Wt 1.7 fl oz (50g)

INGREDIENTS AND APPEARANCE

TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61387-252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
CANDELILLA WAX (UNII: WL0328HX19)
POTASSIUM STEARATE (UNII: 17V812XK50)
ENOXOLONE (UNII: P540XA09DR)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
NIACINAMIDE (UNII: 25X51I8RD4)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DISTEARATE (UNII: 73071MW2KM)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CERAMIDE NP (UNII: 4370DF050B)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61387-252-01	50 g in 1 TUBE; Type 0: Not a Combination Product	08/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/10/2023

Labeler - Claridei Laboratories (035627639)